K243916
- 510(k) number
- K243916
- Device name
- Primus Spinal Fixation System
- Applicant
- Spinal Elements, Inc. CA · US
- Product code
- NKB — Thoracolumbosacral Pedicle Screw System
- Decision date
- 2025-02-21
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243916.pdf
Official FDA record: K243916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.